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NCT06379113RecruitingPhase 2/3

GnRHa + Letrozole in Obese Progestin-insensitive Endometrial Cancer Patients

Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole in Obese Progestin-insensitive Early-stage Endometrial Cancer Patients With Conservative Treatment

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

To investigate the efficacy of GnRHa plus letrozole in obese progestin-insensitive EEC patients.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
29 (estimated)
First submitted
21 Feb 2024
Start date
13 Jul 2022
Primary completion date
30 Mar 2028
Lead sponsor
Xiaojun Chen
NCT number
NCT06379113

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 29
  • From 13 Jul 2022 to the primary completion date, 30 Mar 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Combined with severe medical disease or severely impaired liver and kidney function
  • Pathologically confirmed as endometrial cancer with suspicious myometrial invasion or extrauterine metastasis
  • Patients with other types of endometrial cancer or other malignant tumors of the reproductive system
  • Patients with breast cancer or other hormone- dependent tumors or diseases that cannot be used with GnRHa or Letrozole
  • Acute severe disease such as stroke or heart infarction or a history of thrombosis disease

Other

  • Strong request for uterine removal or other conservative treatment
  • Known or suspected pregnancy
  • Smoker(\>15 cigarettes a day)

Who the study is looking for

  • Have a confirmed initial pathological diagnosis based upon hysteroscopy: histologically prove well-differentiated EEC G1 without myometrial invasion
  • BMI≥30kg/m2
  • No signs of suspicious extrauterine involvement on enhanced magnetic resonance imaging (MRI) or enhanced computed tomography (CT) or ultrasound
  • Using progestin, any of the following therapy, as first-line treatment:
    • Megestrol acetate ≥ 160 mg qd using, combined with Levonorgestrel Lntrauterine System (LNG-IUS) inserted or not
    • Medroxyprogesterone acetate ≥ 250 mg qd using, combined with LNG-IUS inserted or not
    • LNG-IUS inserted
  • Progestin-insensitive:
    • remained with stable disease after 7 months of progestin use
    • did not achieve CR after 10 months of progestin use
  • Have a desire for remaining reproductive function or uterus
  • Good compliance with adjunctive treatment and follow-up

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tenth People's Hospital of Tongji University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
Obstetrics and Gynecology Hospital, Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.